Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
NCT ID: NCT00136981
Last Updated: 2015-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
2003-12-31
2006-11-30
Brief Summary
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To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial hypercholesterolemia
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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torcetrapib/atorvastatin
atorvastatin
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
Exclusion Criteria
* Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid (high doses)
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Hartford, Connecticut, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Chicoutimi, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Québec, Quebec, Canada
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Kuopio, , Finland
Pfizer Investigational Site
OYS, , Finland
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Toul, , France
Pfizer Investigational Site
Brescia, , Italy
Pfizer Investigational Site
Pavia, , Italy
Pfizer Investigational Site
Alkmaar, , Netherlands
Pfizer Investigational Site
Amsterdam, , Netherlands
Pfizer Investigational Site
Delft, , Netherlands
Pfizer Investigational Site
Goes, , Netherlands
Pfizer Investigational Site
Groningen, , Netherlands
Pfizer Investigational Site
Hoorn, , Netherlands
Pfizer Investigational Site
Leiden, , Netherlands
Pfizer Investigational Site
Nijmegen, , Netherlands
Pfizer Investigational Site
Rotterdam, , Netherlands
Pfizer Investigational Site
Sliedrecht, , Netherlands
Pfizer Investigational Site
Utrecht, , Netherlands
Pfizer Investigational Site
Waalwijk, , Netherlands
Pfizer Investigational Site
Parow, Cape Town, South Africa
Pfizer Investigational Site
Parktown, Johannesburg, South Africa
Pfizer Investigational Site
Cape Town, , South Africa
Countries
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References
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Tajik P, Meijer R, Duivenvoorden R, Peters SA, Kastelein JJ, Visseren FJ, Crouse JR 3rd, Palmer MK, Raichlen JS, Grobbee DE, Bots ML. Asymmetrical distribution of atherosclerosis in the carotid artery: identical patterns across age, race, and gender. Eur J Prev Cardiol. 2012 Aug;19(4):687-97. doi: 10.1177/1741826711410821. Epub 2011 May 25.
Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and Radiance 2 Study Groups. Ultrasound protocols to measure carotid intima-media thickness in trials; comparison of reproducibility, rate of progression, and effect of intervention in subjects with familial hypercholesterolemia and subjects with mixed dyslipidemia. Ann Med. 2010 Sep;42(6):447-64. doi: 10.3109/07853890.2010.499132.
Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and 2 Study Groups. Completeness of carotid intima media thickness measurements depends on body composition: the RADIANCE 1 and 2 trials. J Atheroscler Thromb. 2010 May;17(5):526-35. doi: 10.5551/jat.3269. Epub 2010 Mar 13.
Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24.
Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML; RADIANCE 1 and 2 Study Investigators. Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis. Curr Med Res Opin. 2007 Apr;23(4):885-94. doi: 10.1185/030079907x182121.
Kastelein JJ, van Leuven SI, Burgess L, Evans GW, Kuivenhoven JA, Barter PJ, Revkin JH, Grobbee DE, Riley WA, Shear CL, Duggan WT, Bots ML; RADIANCE 1 Investigators. Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia. N Engl J Med. 2007 Apr 19;356(16):1620-30. doi: 10.1056/NEJMoa071359. Epub 2007 Mar 26.
Related Links
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Other Identifiers
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A5091003
Identifier Type: -
Identifier Source: org_study_id
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